FDA applicant

Koven Technology, Inc.

St. Louis, MO18 decisions1994–20211 recall

FDA records 18 decisions for Koven Technology, Inc. (St. Louis, MO) from 1994 to 2021: 18 510(k) clearances. Most are in product codes DPW (Flowmeter, Blood, Cardiovascular) and JOP (Transducer, Ultrasonic). Its devices cite 13 predicates, 4 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Koven Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2007high 1 (2026) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Koven Technology, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Koven Technology, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Koven”

FDA records each applicant name separately; these may or may not be the same firm.

Koven and Assoc., Inc. 8

Koven Technology, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Koven”